FDA Inspection
Horizon Pharmaceuticals, Inc.Horizon Pharmaceuticals, Inc. – FDA Inspection, Feb 16, 2024
Record Details
This FDA Inspection record concerns Horizon Pharmaceuticals, Inc., with an inspection on February 16, 2024, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 58e01881-1480-43d8-a97e-d7f79b53da41
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1230144
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.198(b)(2)Complaint Investigation/Follow-Up Findings
- 21 CFR 211.160(b)(3)Drug product sample
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)(8)Identification of Person Performing Review of Lab Records
- 21 CFR 211.42(c)(10)Aseptic Processing Area
- 21 CFR 211.22(a)Authority lacking to review records, investigate errors
- 21 CFR 211.22(a)Contract drug products--lack of responsibility
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Horizon Pharmaceuticals, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| August 17, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 5, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 5, 2015 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 17, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 26, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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